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Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect (UPTAQE)

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ClinicalTrials.gov Identifier: NCT00534222
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : December 14, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:

With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Condition or disease
Mania Schizophrenia

Study Type : Observational
Actual Enrollment : 387 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Study Start Date : September 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Group/Cohort
Quetiapine
Olanzapine
Risperidone




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Psychiatrist' patients
Criteria

Inclusion Criteria:

  • Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode)
  • Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
  • Patients who are prepared to consent to make the coded data available to AstraZeneca
  • Patients with a CGI ≥ 4

Exclusion Criteria:

  • Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
  • Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
  • Patients unable to give informed consent according to the attending physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534222


Locations
Netherlands
Research Site
Alkmaar, Netherlands
Research Site
Almelo, Netherlands
Research Site
Alphen aan de Rigjn, Netherlands
Research Site
Amersfoort, Netherlands
Research Site
Amstelveen, Netherlands
Research Site
Amsterdam, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Medical Director AstraZeneca

ClinicalTrials.gov Identifier: NCT00534222     History of Changes
Other Study ID Numbers: NIS-NNL-SER-2005/1
NL 401241 ( Registry Identifier: NIS )
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: April 2009

Keywords provided by AstraZeneca:
Patients with a manic episode
Patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the CGI at baseline

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs